This is a trial to look at the treatment of Downs Syndrome patients with Lithium Carbonate versus placebo

Phase 1

• Conditions: Down's Syndrome; MedDRA version: 14.0Level: LLTClassification code 10013616Term: Down's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2008-008342-20-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-09
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

•Individuals with Down Syndrome
•Over the age of 18 years
•Able to provide informed consent or have a legal representative to consent on their behalf if they lack capacity
•Able to communicate with the investigator and to comply with requirements of the study
•Has carer support

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Individuals with contraindications to lithium treatment
•Individuals with contraindications to undergoing a magnetic resonance scan
•Non-compliance with taking of the tablets between baseline and the 4-week assessment
•Treatment with lithium within the last 6 months
•Evidence of dementia
•Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified